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A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifampin-Based Tuberculosis Treatment Versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifabutin-Based Tuberculosis Treatment With or Without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV

Brief Summary

There is a rapidly-growing need to identify evidence-based, safe, and effective co-treatment regimens for HIV-related tuberculosis (TB) among patients who require protease inhibitor-based antiretroviral therapy. This study will compare three alternative co-treatment options among participants in high TB endemic resource-constrained settings, in which one co-treatment option explores if an additional anti-HIV drug needs to be used when patients are being treated with a protease inhibitor together with rifabutin-based anti-TB treatment.

Accrual will take place in two accrual periods. Accrual period 1 will enroll 60 participants who will undergo an initial dose-finding period before continuing regular study follow-up. Once the review of the dose-finding pharmacokinetic and safety data from accrual period 1 participants is completed, accrual period 2 will begin.

Confirmed or probable pulmonary or extrapulmonary TB (more information on the criterion can be found in the protocol)

Chest x-ray within 30 days prior to study entry.

A PI-based antiretroviral (ART) regimen is required, as determined by the participant's primary clinician/clinical facility.

Certain laboratory values obtained within 14 days prior to study entry (more information on the criterion can be found in the protocol)

For females of reproductive potential, negative serum or urine pregnancy test within 7 days prior to study entry and 72 hours of starting study medications.

Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs.

Karnofsky performance score > 40 within 14 days prior to study entry, and likelihood of survival, in the opinion of the site investigator, for at least 6 months.

Ability to swallow oral medications.

Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria:

History of completed TB treatment and resolution of TB symptoms less than 1 year prior to the current TB episode at study entry, or incomplete treatment for a prior episode of TB (i.e., defaulted past TB treatment) at any time prior to the current TB episode.

Participants infected with a rifamycin resistant strain of TB (more information on the criterion can be found in the protocol).

Receipt of more than 28 cumulative days of anti-TB treatment for the current TB episode prior to study entry.

Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry, or that in the opinion of the site investigator, might otherwise interfere with adherence to study requirements.

Pregnant or breastfeeding.

Anticipated receipt of prohibited medications (more information on the criterion can be found in the protocol).

Known intolerance/allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.

History of close contact with known MDR or XDR TB patients at any time prior to study entry.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects